Agency classClass IIOur severity:High FDA (Devices)·Z-0456-2019·Announced 2018-11-21

American Contract Systems Recalls Powdered Surgical Gloves

American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a banned substance used in a high-risk medical context (surgery) where the barrier function is critical for infection control, fitting the 'High' criteria for risk-of-harm products.

Plain-English summary

American Contract Systems, Inc. is recalling 1,180 kits of Powdered Surgical Gloves. The affected products include Baxter and Ansell brand Powdered Surgical Gloves, as well as powdered surgical gloves included in ACS surgical convenience kits. These products were distributed to states in Illinois, Missouri, Nebraska, and Ohio.

The recall is being conducted because powdered surgical gloves are an FDA banned substance. Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery and patient interactions.

Consumers and health care facilities should stop using the affected gloves immediately. Specific tray numbers and codes for the recalled units are available in the official recall documentation.

The recalled product

Product: Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and…
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Gloves
Hazard: banned-substance
infection-risk
Affected units: 1,180

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

Tray Number (Powdered Glove code): MHCE23D (ANS5711104)
MHAP41D (ANS7825)
MHOC43C (ANS7825)
MHPO42D (ANS7825)
GVTH071 (ANS5711104)
GVTK05L (ANS5711104)
GVTK05M (ANS5711104)
CXTR68D (ANS5711105)
MDEY35H (BAX2D7202I)
MDEY35I (BAX2D7202I)
FHLV24 (ANS5711105
ANS5711101)
LKCA02A (ANS5710503)
WIDE32 (ANS7824)
UTLU70F (ANS7825)
FIOH02H (BAX2D7254)

Distribution

Distributed in 4 states:

Same manufacturer · American Contract Systems, Inc.

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Same hazard · banned substance